Inspections, Compliance, Enforcement, and Criminal Investigations
Morrell Farm 12-Dec-05
Department of Health and Human Services
Public Health Service
New York District
December 12, 2005
WARNING LETTER NYK 2006-04
RETURN RECEIPT REQUESTED
Mr. Laverne Morrell, Owner
545 Christian Hill Road
Franklin, New York 13775
Dear Mr. Morrell:
An investigation of your dairy operation located at 9873 Walton Franklin Road, Franklin, New York, that was conducted by a representative of the U.S. Food and Drug Administration on August 11 and 18, 2005, confirmed that you offered an animal for sale for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed you caused the new animal drug, Pen-Aqueous Penicillin G Procaine Injectable Suspension (NADA 065-010), to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. § 360b]. You can find the Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov.
On or about February 2, 2005, you consigned a dairy cow with Back Tag No. B755 for slaughter as food at [redacted]. On or about February 4, 2005, this animal was slaughtered at [redacted]. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from that animal identified the presence of 0.34 parts per million (ppm) penicillin in liver tissue and 0.67 ppm in kidney tissue. A tolerance of 0.05 ppm has been established for residues of penicillin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (CFR), Section 556.510(a) [21 CFR 556.510(a)]. The presence of this drug in the edible tissues of this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(ax2)(C)(ii)].
Our investigation also found that you hold animals under conditions so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous drugs from edible tissues. For example, you failed to maintain complete treatment records and you lacked an adequate inventory system for determining the quantities of drugs used to medicate your animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act [21
U.S.C. § 342(a)(4)].
In addition, you adulterated Pen-Aqueous Penicillin G Procaine Injectable Suspension (NADA 065-010) within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] when you failed to use the drug in conformance with its approved labeling. "Extralabel use," i.e., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(ax5) [21 U.S.C. § 360b((a)(5)] of the Act and 21 CFR Part 530. Our investigation found that your extralabel use of Pen-Aqueous Penicillin G Procaine Injectable Suspension (NADA 065-010) failed to comply with these requirements. For example, you administered the Pen-Aqueous Penicillin G Procaine Injectable Suspension (NADA 065-010) without following the dosage level and withdrawal period set forth in the approved labeling, and you did so without the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a). Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 CFR 530.11(d). Because your extralabel use of this drug was not in compliance with 21 CFR Part 530, the drug was unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and your use caused it to be adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 301(a)(5)].
The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction. You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at (716) 551-4461, ext. 3168.
Jerome G. Woyshner
New York District